Drug Side Effects Up, But Benefits Up More

The news of a marked increase in adverse drug events reported to the FDA is sure to be one more arrow for those taking aim at "big pharma" and the FDA. The criticism is off target, however, because it fails to take into account the new ways drugs are being used.

From 1998 to 2005, the number of serious adverse effects from medicines reported to the FDA more than doubled, according to a report published in this week's Journal of the American Medical Association (JAMA). "These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," write the researchers from the Institute for Safe Medication Practices, in Pennsylvania.

The data may be accurate, but without a deeper understanding about how important innovations have changed the way doctors practice medicine, the numbers lack context and are worse than useless in terms of public policy. This information may further skew the drug approval process towards excessive caution, leading to even more lives lost because of delays in getting drugs to market in the unrealistic search for 100 percent "safe" medication.

When doctors had little more than aspirin and penicillin at their disposal, adverse drug effects were far lower than they are today (but still not nil), but there were far fewer conditions they could even dream of treating with drugs, and patients suffered because of it. We could easily improve "drug safety," in a narrow sense of the phrase, by turning back the pharmaceutical clock 10, 20, or even 50 years. But we all know such a move would be to the detriment of public health -- even though we'd thereby eliminate the risks that come from new drugs as highlighted in this latest report.

Similarly, slowing down the approval process today would hamper innovation --no help to those who would die without trying a risky new medical approach.

Consider as an analogy the "safety" record of the world's top cardiologists. The authors of the JAMA report might find that twice as many patients die under the care of these top doctors than under the care of local physicians. It doesn't take a brain surgeon to realize that's not because the specialists aren't good -- it is that their reputation attracts the most difficult and risky cases. The same is true with some of the pharmaceuticals studied between 1998 and 2005.

Doctors are calling on medications to do things we never thought possible. Statin drugs, as one example, have contributed to the dramatic decline in cardiovascular mortality over the past 20 years. Just two decades ago, without these therapies, many patients died as expected -- from diseases instead of (occasionally) from drug side effects.

Weigh the lives saved by new drugs against the ones lost because of them and you'd draw a very different lesson than this report: hurry up and get new drugs to market, then let patients and physicians weigh the risks and the benefits and make an informed decision. In the meantime, people are dying to make a choice.